Single vs. Dual Implant Fixation for Distal Femur Fractures in Older or Compromised Adults

NCT ID: NCT06944964

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2030-05-01

Brief Summary

The goal of this clinical trial is to assess the feasibility of conducting a larger study comparing single implant fixation (SIF) and dual implant fixation (DIF) for treating distal femur fractures (DFF) in older or compromised adults. It will also evaluate the safety and effectiveness of these treatments. The main questions it aims to answer are:

• Can DIF improve patient outcomes compared to SIF in older or compromised adults?
• How feasible is it to recruit and retain participants for this trial?

Participants will:

1. Be randomly assigned to receive either SIF or DIF for their DFF treatment

2. Visit the clinic for follow-ups and assessments of their recovery and bone healing, including potential ultrasound imaging for detecting complications like non-union.

Detailed Description

The Investigators aim to conduct a multi-centre, preliminary RCT to determine the feasibility and inform the design of a definitive trial comparing patient-important outcomes between patients aged 40 years and older with distal femur fractures managed with SIF vs. DIF.

Primary Aim: Evaluate the feasibility of conducting a larger, definitive trial examining outcomes following SIF vs. DIF for DFFs in older or compromised adults. Our primary outcomes for this objective will be 1) recruitment and retention at the participating sites; and 2) site investigator feedback regarding barriers to protocol adherence.

Secondary Aims: Pilot the collection of candidate outcome measures to determine the optimal primary end point and sample size for a definitive trial. Our primary outcome for this objective will be the Oxford Knee Score, and secondary outcomes will include a range of patient-reported quality of life (QOL) measures, and objective clinical measures.

In addition, the study includes an ultrasound sub-study aimed at evaluating the feasibility of using ultrasound imaging to monitor bone healing and detect complications like non-union in patients with DFF.

Participants will be randomly assigned to receive either SIF or DIF, with SIF generally involving a single implant (such as a lateral locked plate or retrograde intramedullary nail) and DIF using a combination of implants (e.g., dual plates or a nail and plate). This randomized design will enable us to assess whether dual implant fixation offers improved clinical outcomes, such as reduced morbidity and faster weight-bearing recovery, compared to the more traditional single implant fixation.

Non-Randomized Participation: The investigators will collect data surrounding the number of eligible patients approached for consent, eligible patients not approached for consent and reason why, along with the proportion of patients who do not consent and reasons why to refine our strategy for the definitive trial. For patients who are excluded due to a lack of clinical equipoise, the investigators will provide the option of participating in a concurrent cohort study.This study will record the same variables as the RCT.

The trial will take place at four major trauma centers across Canada: London Health Sciences Centre - Victoria Hospital, St. Michael's Hospital, Sunnybrook Health Sciences Centre, and Alberta Health Services Centre. Participants will receive follow-up visits at these centers, which will include clinical check-ups, rehabilitation sessions, and imaging assessments to track their recovery progress.

The data gathered from this feasibility study will provide critical insights into the practicality of a larger-scale trial and will help inform future treatment strategies for distal femur fractures.

Conditions

Distal Femur Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A (Control): Single Implant Fixation (SIF)

Patients in this arm will undergo fixation of distal femur fractures using a single implant, which could be a lateral locked plate or a retrograde intramedullary nail.

Group Type: ACTIVE_COMPARATOR

Single Implant Fixation (SIF)

Intervention Type: PROCEDURE

This intervention involves using one implant for fracture fixation. The implant can be either a lateral locked plate or a retrograde intramedullary nail, based on the surgeon's preference.

Group B (Experimental): Dual Implant Fixation (DIF)

Patients in this arm will undergo fixation using dual implants, either dual plate fixation or a combination of nail and plate fixation.

Group Type: ACTIVE_COMPARATOR

Dual Implant Fixation (DIF)

Intervention Type: PROCEDURE

This intervention involves using two implants for fracture fixation. The combination can be either dual plate fixation (DPF) or combination nail plate fixation (NPF) .

Interventions

Single Implant Fixation (SIF)

This intervention involves using one implant for fracture fixation. The implant can be either a lateral locked plate or a retrograde intramedullary nail, based on the surgeon's preference.

Intervention Type: PROCEDURE

Dual Implant Fixation (DIF)

This intervention involves using two implants for fracture fixation. The combination can be either dual plate fixation (DPF) or combination nail plate fixation (NPF) .

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Isolated DFF (native AO/OTA-type A2, A3, C or periprosthetic Lewis and

Rorabeck type 1, 2) and either:

1. Age ≥ 60 years or;

2. Age 18-60 years with one or more of:

i. Osteoporosis ii. Obesity (Body Mass Index >30) iii. Metaphyseal comminution iv. Diabetes

2. Fracture amenable to plating and nailing

3. Ability to read and speak English or availability of a translator

4. Acute fractures (within 14-days of injury)

5. No surgeon preference regarding SIF vs. DIF

6. Provision of informed consent

Exclusion Criteria

1. Candidate for primary or revision arthroplasty (surgeon opinion)

2. Periprosthetic fracture with loose implant

3. Gustillo grade III open fractures

4. Ipsilateral hip implant

5. Likely problems, in the judgment of the investigators, with maintaining follow-up (i.e., no fixed address, mentally competent to give consent, etc.)

6. Non-ambulatory patients

7. Multi-trauma patient (Injury Severity Score ≥ 16)

8. Lack of bone substance or poor bone-quality which, in the surgeon's judgment, makes fixation impossible

9. Any concomitant lower-extremity injury

10. Inability to obtain informed consent due to language barrier

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Orthopaedic Trauma Association

OTHER

Sponsor Role: collaborator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fraser Orthopaedic Institute

New Westminster, British Columbia, Canada

Site Status: NOT_YET_RECRUITING

London Health Sciences Centre

London, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Emil Schemitsch, MD, FRCS(C)

Role: CONTACT

Emil.Schemitsch@lhsc.on.ca

519-685-8500 ext. 33307

Abdel-Rahman Lawendy, MD, FRCS(C)

Role: CONTACT

AbdelRahman.Lawendy@lhsc.on.ca

519-685-8500 ext. 58086

Facility Contacts

David Cinats, MD, FRCS(C)

Role: primary

604-545-1405

Lawson Health Research Institute

Role: primary

519-685-8500

Other Identifiers

DFF Feasibility Study

Identifier Type: -

Identifier Source: org_study_id